A company developing a bispecific antibody that already has clinical data in blood cancers has raised more than $60 million in its latest venture capital funding round that it plans to use to advance the drug in solid tumors.
South San Francisco, California-based Amphivena Therapeutics said Tuesday that it had raised $62 million in a Series C round, which NanoDimension and Qiming Venture Partners co-led. New investors included Clough Capital, Aju IB, Korys Merieux, Kaitai Capital, Industrial Investors and Nawton Limited, along with insider investors MPM Capital and funds managed by Tekla Capital Management and Franklin Berger.
The company is developing a bispecific T-cell engager antibody called AMV564, which targets CD33 and CD3. Such antibodies are immunotherapies designed to work by targeting both cancer cell-surface proteins and proteins expressed on the surfaces of T cells, enabling the latter to kill the former. The company has been developing the drug for acute myeloid leukemia and myelodysplastic syndromes, and it is currently in a Phase I study among relapsed or refractory AML. The drug is designed to eliminate myeloid-derived suppressor cells, or MDSCs, while sparing normal neutrophils and monocytes. In addition to MDS and AML, the drug is in a Phase I study for solid tumors that the company said is open for enrollment, though searches for the name of the company of the drug on ClinicalTrials.gov only turned up the MDS and AML trials.
Updated data from the AML study presented at the European Hematology Association’s 2019 annual meeting in July from 33 patients across nine dose cohorts showed a complete response, a complete response with incomplete hematological recovery and a partial response. Grade 1 and 2 cytokine release syndrome – a side effect sometimes observed with bispecific antibodies – also occurred.
Amgen’s Blincyto (blinatumomab) is a bispecific T-cell engager currently on the market. The drug targets the CD19 antigen in acute lymphoblastic leukemia. Amgen is developing another bispecific antibody, AMG 420, that targets the BCMA antigen in multiple myeloma and produced a 70 percent overall response rate among patients who received the drug at 400 micrograms, the dose recommended for further study. Another bispecific antibody on the market is Roche’s Hemlibra (emicizumab-kxwh), used to treat hemophilia A.
In late June, the Food and Drug Administration issued a draft guidance for companies developing bispecific antibodies, in oncology as well as other disease areas. However, an expert said the guidance was flawed because it did not distinguish between Blincyto and Hemlibra’s very different mechanisms of action, despite both products falling under the category of “bispecific.”
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